| CTRI Number |
CTRI/2025/08/093726 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Enhancing the Effect of Nerve Blocks in upper limb Surgery with Dexmedetomidine |
|
Scientific Title of Study
|
Effect of adding dexmedetomidine to lignocaine with adrenaline in supraclavicular brachial plexus block for approval of subject |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harish |
| Designation |
resident doctor |
| Affiliation |
Government multispeciality hospital |
| Address |
Department of anaesthesia government multi-specialty hospital Chandigarh sector 16
Chandigarh
CHANDIGARH
160016
India |
| Phone |
07202071268 |
| Fax |
|
| Email |
harshpushpabajiya17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vineet kaur |
| Designation |
SMO and guide |
| Affiliation |
Government multispeciality hospital |
| Address |
Department of anaesthesia government multi-specialty hospital Chandigarh sector 16
Chandigarh
CHANDIGARH
160016
India |
| Phone |
9876797338 |
| Fax |
|
| Email |
kaurvineet1973@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sabhayata sharma |
| Designation |
SMO and coguide |
| Affiliation |
Government multispeciality hospital |
| Address |
Department of anaesthesia government multi-specialty hospital Chandigarh sector 16
Chandigarh
CHANDIGARH
160016
India |
| Phone |
9814683689 |
| Fax |
|
| Email |
sanjeevsabhayata@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government multispeciality hospital sector 16 A |
|
|
Primary Sponsor
|
| Name |
goverment multispeciality hospital sector |
| Address |
sector 16 A Chandigarh pin code 160016 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Government multispeciality hospital |
Sector 16 A Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harish |
govt. multispeciality hospital |
Emergency building ICU complex first floor department of anaesthesia GMSH Sector 16A chandigarh pin code 160016
Chandigarh
CHANDIGARH |
07202071268
harshpushpabajiya17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| the institutional ethics committee of govt. multispeciality hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomidine |
Patients will receive 7 milligram per kilogram body weight 1.5 percentage lignocaine adrenaline with 50 microgram (0.5 ml) dexmedetomidine in supraclavicular brachial plexus bock, total duration of surgery less then 2 hour |
| Comparator Agent |
Normal saline |
Patients will receive 7 milligram per kilogram body weight 1.5 percentage lignocaine with adrenaline mixed with 0.5 ml sterile normal saline in supraclavicular brachial plexus bock, total duration of surgery less then 2 hour. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA1 and ASA2,2)Age group between 18 to 60 years,3)Patient giving consent for study
|
|
| ExclusionCriteria |
| Details |
severe respiratory and cardiovascular disease patients,sensitivity to study drug,known history of bleeding tendency or deranged coagulogram,duration of surgery more than 2 hours,patients with neurodeficit involving brachial plexus,pregnant patients,patients on any alpha2 agonist or antagonist tratment,drug abusers and psychiatric patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to determine the duration of analgesia |
12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the onset and duration of sensory and motor block,To determine the effect on haemodynamic parameters,To observe side effects, if any.
|
12 hours |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
08/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
this is prospective double blind randomized controlled study, we will be evaluating the effect of adding dexmedetomidine to 1.5 percentage lignocaine adreanaline in ultrasound guided supraclavicular brachial plexus block for upper limb orthopaedic surgeries in terms of duration of analgesia, onset and duration of sensory and motor block, effect on haemodynamic parameters and adverse effects to technique or drugs under study at govt. multispeciality hospital sector 16 A chandigarh |